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Chronic Hepatitis CPhase 3INSIGHTNCT01513941

An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)

A Phase 3 study testing Telaprevir, Ribavirin and Pegylated-Interferon-alfa-2a in people with Chronic Hepatitis C, run by Janssen-Cilag International NV at 31 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Telaprevir, Ribavirin and Pegylated-Interferon-alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
31 sitesin 8 countries
Study dates
Apr 2012to Jun 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic (detectable HCV Ribonucleic acid (RNA) more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level greater than 1,000 IU/mL
  • Confirmed diagnosis of HIV-1 infection greater than 6 months before the screening visit
  • CD4 count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit
  • HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit
  • No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit
  • Currently taking one of the permitted anti-HIV regimens for greater than or equal to12 weeks

Who cannot join

  • Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period
  • Infection or co-infection with HCV other than genotype 1
  • Contraindication to the administration of Peg-IFN-alfa or RBV
  • Hepatitis B virus (HBV) co-infection
  • Acute or active condition of HIV-associated opportunistic infection within 6 months of screening

Trial locations and contacts

31 sites in 8 countries.

31 sites in 8 countries

Spain8 sites

  • Study site

    Alicante

  • Study site

    Badalona

  • Study site

    Córdoba

  • Study site

    Donostia / San Sebastian

  • Study site

    Elche

  • Study site

    Madrid

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

Russia5 sites

  • Study site

    Krasnodar

  • Study site

    Perm

  • Study site

    Saint Petersburg

  • Study site

    Smolensk

  • Study site

    Voronezh

Other trials in Russia

Brazil4 sites

  • Study site

    Campinas

  • Study site

    Rio de Janeiro

  • Study site

    Santo André

  • Study site

    São Paulo

Other trials in Brazil

France4 sites

  • Study site

    Le Kremlin-Bicêtre

  • Study site

    Marseille

  • Study site

    Nice

  • Study site

    Paris

Other trials in France

Australia3 sites

  • Study site

    Cairns

  • Study site

    Darlinghurst

  • Study site

    Melbourne

Other trials in Australia

Poland3 sites

  • Study site

    Bydgoszcz

  • Study site

    Mysłowice

  • Study site

    Warsaw

Other trials in Poland

United Kingdom3 sites

  • Study site

    Birmingham

  • Study site

    Glasgow

  • Study site

    London

Other trials in United Kingdom

Sweden1 site

  • Study site

    Stockholm

Other trials in Sweden

About this study

Official title: Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects With Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection

The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).

Read the detailed description

This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). Approximately 150 patients infected with both chronic HCV-1 and HIV-1 are planned to be enrolled.

Being tested
Telaprevir, Ribavirin, Pegylated-Interferon-alfa-2a
Keywords
Chronic hepatitis C, Genotype 1 chronic hepatitis C, Treatment experienced with HCV-1/HIV-1 coinfection, Telaprevir, Pegylated-Interferon-alfa-2a, Ribavirin, HCV-1/HIV-1 coinfection, Hepatitis C
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelaprevirDrug

    Type=exact number, unit=mg, number=750 or 1125, form=tablet, route=oral. the patients will receive 2 oral tablets every 8 hours for 12 weeks except for patients on efavirenz who will receive 1125mg (3 oral tablets) every 8 hours for 12 weeks.

  • RibavirinDrug

    Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy.

  • Pegylated-Interferon-alfa-2aDrug

    Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.

Study groups in NCT01513941
Study groupRoleWhat they receive
Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV)ExperimentalAll patients who will receive 12 weeks of treatment with telaprevir 750 mg q8h except for patients on efavirenz will receive 1125 mg every 8 hours (q8h) in combination with Pegylated-Interferon-alfa-2a (Peg-IFN-alfa-2a) 180 μg/week and RBV 800 mg/day. At Week 12, telaprevir dosing will end and the patients will continue on Peg-IFN-alfa-2a and RBV.
Receives: Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated-Interferon-alfa-2a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

    Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.

    Measured: Up to 48 weeks

Secondary outcomes (10)

  1. Change from baseline in log HCV RNA values

    Change from baseline in log HCV RNA values at each time point during treatment.

    Measured: Baseline and week 48

  2. Proportiond of patients achieving undetectable HCV RNA levels

    Proportion of patients achieving SVR24 planned, defined as having undetectable plasma HCV RNA levels 24 weeks after the last planned dose of study medication.

    Measured: Up to 48 weeks

  3. Proportion of patients achieving undetectable HCV RNA levels at Week 4

    The proportion of patients who achieve rapid virologic response (RVR) and undetectable HCV RNA levels at Week 4 of treatment.

    Measured: Up to 48 weeks

  4. Proportion of patients achieving undetectable HCV RNA levels at Week 12

    Proportion of patients achieving undetectable HCV RNA levels at Week 12 of treatment.

    Measured: Up to 48 weeks

  5. Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR)

    Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 of treatment (eRVR).

    Measured: Up to 48 weeks

  6. Proportion of patients achieving undetectable HCV RNA at the actual end of treatment

    Proportion of patients having undetectable HCV RNA levels at the actual end of treatment (ie, Week 24, Week 48, or early discontinuation).

    Measured: Up to 48 weeks

  7. Proportion of patients achieving less than 25 IU/mL

    Proportion of patients having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).

    Measured: Up to 48 weeks

  8. Proportion of patients with on-treatment virologic failure

    Proportion of patients with on-treatment virologic failure (an increase greater than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA greater than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).

    Measured: Up to 48 weeks

  9. Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels

    Proportion of patients who relapse (having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA levels (less than 25 IU/mL, undetectable) at planned end of treatment.

    Measured: Up to 48 weeks

  10. Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels

    Proportion of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA less than 25 IU/mL at planned end of treatment.

    Measured: Up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionMar 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513941
Sponsor's protocol ID
CR100778
Other IDs
VX-950HPC3008, 2011-004928-35
Acronym
INSIGHT
Status last verified
May 2016
First submitted
16 Jan 2012
Last updated
5 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Montes ML, Nelson M, Girard PM, Sasadeusz J, Horban A, Grinsztejn B, Zakharova N, Rivero A, Durant J, Ortega-Gonzalez E, Lathouwers E, Janssen K, Ouwerkerk-Mahadevan S, Witek J, Gonzalez-Garcia J. Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study. J Antimicrob Chemother. 2016 Jan;71(1):244-50. doi: 10.1093/jac/dkv323. Epub 2015 Oct 19.

    PubMed 26483516

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telaprevir, Ribavirin and Pegylated-Interferon-alfa-2a in people with Chronic Hepatitis C, run by Janssen-Cilag International NV at 31 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Spain, Russia, Brazil, France, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels (time frame: Up to 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01513941, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.

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